Titration with oxymorphone extended release to achieve effective long-term pain relief and improve tolerability in opioid-naive patients with moderate to severe pain.
OBJECTIVE
Assess the effectiveness and tolerability of a program of gradual dose titration with oxymorphone extended release (ER) for treatment of moderate to severe chronic pain in opioid-naive patients.


METHODS
Open-label, nonrandomized 6-month study with a titration/stabilization period of <or=1 month followed by a 5-month maintenance period.


METHODS
Multidisciplinary pain centers in the United States.


METHODS
Adult opioid-naive patients with moderate to severe chronic pain.


METHODS
Patients were gradually titrated from a 5-mg dose of oxymorphone ER (taken every 12 hours) to a stabilized dose that provided effective pain relief and was well tolerated.


METHODS
Brief Pain Inventory Short Form questions 5 and 9, patient and physician global assessments of pain relief, adverse events (AEs), and discontinuations.


RESULTS
The majority (94/126; 75%) of patients were stabilized on a dose of oxymorphone ER that provided effective pain relief with tolerable AEs. Most (81/94; 86%) required <24 days to reach a stable dose. Sixteen percent of patients in the titration period and 17% of patients in the maintenance period discontinued because of AEs possibly or probably related to oxymorphone ER. Patients completing the entire 5-month maintenance period experienced effective pain relief with significant (>50%) reductions of pain interference with quality-of-life measures. There was minimal dose escalation over the 5 months and low use of rescue medication.


CONCLUSIONS
Oxymorphone ER provided effective pain relief from moderate to severe chronic pain in opioid-naive patients. Gradual titration was well tolerated, with a low rate of discontinuations caused by AEs.
Rauck
Richard
R
Carolinas Pain Institute, Wake Forest University, Winston-Salem, North Carolina 27103, USA. rrauck@ccrpain.com
Ma
Tina
T
Kerwin
Rosemary
R
Ahdieh
Harry
H
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010111:Oxymorphone / Q000008:administration & dosage* / Q000009:adverse effects; D010146:Pain / Q000175:diagnosis* / Q000188:drug therapy*; D010147:Pain Measurement / Q000187:drug effects*; D016896:Treatment Outcome; D014481:United States
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D010111:Oxymorphone